In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents protecting Epogen®. Notably, the damages relate to product that Pfizer is not yet approved to sell in the United States. The jury found that Pfizer’s subsidiary Hospira, in manufacturing its proposed biosimilar ahead of FDA approval, was not protected by the statutory safe harbor covering pre-marketing regulatory uses (35 U.S.C. § 271(e)(1)).

In the United States, both Amgen (under the tradename Epogen®) and Johnson & Johnson (under the tradename Procrit®) market erythropoietin alfa (“EPO”), a blockbuster biologic drug used to treat anemia. EPO is a complex glycosylated protein produced in genetically engineered mammalian cells. In early 2015, FDA accepted Hospira’s abbreviated Biologics License Application (aBLA) for a biosimilar version of EPO for review. Amgen later sued Hospira in the District of Delaware asserting infringement of two patents relating to the manufacture of EPO. One covered specific EPO isoforms and methods of selecting them; the other covered a cell line suitable for making EPO. At the time of the lawsuit, the cell line patent had already expired, and the isoform patent would expire shortly.

Hospira defended against Amgen’s infringement claims by arguing, among other things, that its manufacturing activities were protected by the statutory safe harbor of 35 U.S.C. § 271(e)(1). Section 271(e)(1) exempts a drug maker from liability for infringement if the otherwise infringing activity is “solely for uses reasonably related to the development and submission of information” required by the FDA. Hospira argued that 21 batches of its biosimilar – manufactured prior to patent expiration – were prepared for the purpose of submitting information to the FDA in support of its aBLA. According to Hospira, these batches were therefore reasonably related to obtaining FDA approval and protected by the safe harbor.

The jury disagreed. Following a five-day trial, the jury returned a verdict finding that Hospira infringed Amgen’s isoform patent, that the patent was valid, and that 14 of the 21 batches of the biosimilar were not protected by the safe harbor. The jury awarded Amgen $70 million in reasonable royalty damages for infringement of its patent. Notably, the award comes prior to any actual biosimilar sales in the United States, as FDA has yet to approve Hospira’s aBLA due to FDA’s concerns with a manufacturing facility for the biosimilar.

This case is a lesson to innovators and biosimilar makers alike on the value of expired or soon-to-expire patents. In deciding which patents to assert in BPCIA litigation, innovators should consider their entire patent portfolio, including recently expired manufacturing patents. Biosimilar makers similarly should be aware that pre-approval batches will not necessarily be exempt from infringement, even if the relevant patents are due to expire prior to FDA approval. Such patents not only are in play, but also – especially in the high-stakes biologics market – may result in significant damages awards.